Preterm Rupture of MembranesNCT04318470
Identification of Microbial DNA in Maternal Plasma After PPROM
An observational study of Preterm Rupture of Membranes, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study evaluates the use of metagenomic next generation sequencing in identifying microbial DNA in plasma samples of patients with preterm premature rupture of membranes. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Rupture of Membranes
- What is being tested?
- mNGS
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant patients with preterm premature rupture of membranes and gestational-age-matched controls
Who may be able to join
- For PPROM group, preterm premature rupture of membranes between 16 0/7 and 33 6/7 weeks of gestation
- For control group, healthy pregnancy with no evidence of preterm premature rupture of membranes or other major complications
Who cannot join
- Maternal age < 18 years
- Major fetal congenital malformation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94158
About this study
Official title: Using Metagenomic Next-generation Sequencing to Identify Microbial DNA in Maternal Plasma in Cases of Preterm Premature Rupture of Membranes
This study evaluates the use of metagenomic next generation sequencing in identifying microbial DNA in plasma samples of patients with preterm premature rupture of membranes.
Read the detailed description
Although preterm premature rupture of membranes (PPROM) occurs in only 3% of pregnancies, it accounts for 30% of preterm births (PTB) and is associated with serious maternal and neonatal morbidity. An important factor in the underlying pathophysiology of PPROM and subsequent PTB is subclinical infection, which promotes a cascade of events that contribute to synthesis of prostaglandins, release of proinflammatory cytokines, infiltration of neutrophils, and activation of metalloproteases. Over time, enhanced activity of these infectious and inflammatory pathways contributes to the development of spontaneous labor and/or overt intraamniotic infection (IAI). Unfortunately, the majority of patients with PPROM do not manifest signs and symptoms of infection that are detectable by clinical examination, laboratory evaluation, and traditional microdiagnostic tests, and attempting to predict length of latency period and/or timing of delivery remains a clinical challenge. We propose the use of metagenomic next-generation sequencing (mNGS) to identify microbial DNA in maternal plasma following PPROM. We hypothesize that the presence and abundance of microbial DNA is associated with a shorter latency period and that an increase in the abundance of microbial DNA precedes delivery.
- Conditions
- Preterm Rupture of Membranes
- Being tested
- mNGS
- Medical subject headings
- Fetal Membranes, Premature Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mNGSDiagnostic test
Metagenomic next generation sequencing for microbial DNA
| Study group | Role | What they receive |
|---|---|---|
| PPROM | Preterm premature rupture of membranes between 16 0/7 and 33 6/7 weeks gestation Receives: Diagnostic Test: mNGS | |
| Healthy controls | Gestational-age-matched controls without preterm premature rupture of membranes or other pregnancy complications Receives: Diagnostic Test: mNGS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of latency
Time between PPROM and delivery
Measured: From study enrollment to date of delivery, up to 24 weeks
Secondary outcomes (10)
Maternal infectious morbidity
Composite of fever, intrauterine infection, sepsis, postpartum endometritis, surgical site infection, and administration of antibiotics
Measured: From study enrollment to date of delivery, up to 30 weeks
Neonatal infectious morbidity
Composite of fever, sepsis, administration of antibiotics, and need for blood/urine/cerebrospinal fluid (CSF) cultures
Measured: From neonatal birth to neonatal hospital discharge, up to 1 year
Histopathological signs of infection
Histopathological signs of infection on routine post-delivery examination of placenta, membranes, and umbilical cord
Measured: At time of placental delivery
Perinatal demise
Composite of intrauterine fetal demise and neonatal demise
Measured: From study enrollment to 28 days of life
Admission to neonatal intensive care unit (NICU)
Measured: From neonatal birth to neonatal hospital discharge, up to 1 year
NICU length of stay
Measured: From neonatal birth to neonatal hospital discharge, up to 1 year
Neonatal need for supplemental oxygen
Measured: From neonatal birth to neonatal hospital discharge, up to 1 year
Respiratory distress syndrome
Measured: From neonatal birth to neonatal hospital discharge, up to 1 year
Necrotizing enterocolitis
Measured: From neonatal birth to neonatal hospital discharge, up to 1 year
Intraventricular hemorrhage
Measured: From neonatal birth to neonatal hospital discharge, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start12 Feb 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Rupture of MembranesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nasim C Sobhani, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318470
- Sponsor's protocol ID
- 10-00505-JD
- Status last verified
- Apr 2023
- First submitted
- 10 Mar 2020
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Metagenomic Next-generation Sequencing to Identify Microbial DNA in Maternal Plasma in Cases of Preterm Premature Rupture of Membranes
- ClinicalTrials.gov ID
- NCT04318470
- Acronym / sponsor ID
- 10-00505-JD
- Conditions
- Preterm Rupture of Membranes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 24 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the use of metagenomic next generation sequencing in identifying microbial DNA in plasma samples of patients with preterm premature rupture of membranes.
Detailed description
Although preterm premature rupture of membranes (PPROM) occurs in only 3% of pregnancies, it accounts for 30% of preterm births (PTB) and is associated with serious maternal and neonatal morbidity. An important factor in the underlying pathophysiology of PPROM and subsequent PTB is subclinical infection, which promotes a cascade of events that contribute to synthesis of prostaglandins, release of proinflammatory cytokines, infiltration of neutrophils, and activation of metalloproteases. Over time, enhanced activity of these infectious and inflammatory pathways contributes to the development of spontaneous labor and/or overt intraamniotic infection (IAI). Unfortunately, the majority of patients with PPROM do not manifest signs and symptoms of infection that are detectable by clinical examination, laboratory evaluation, and traditional microdiagnostic tests, and attempting to predict length of latency period and/or timing of delivery remains a clinical challenge. We propose the use of metagenomic next-generation sequencing (mNGS) to identify microbial DNA in maternal plasma following PPROM. We hypothesize that the presence and abundance of microbial DNA is associated with a shorter latency period and that an increase in the abundance of microbial DNA precedes delivery.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPROM | – | Diagnostic Test: mNGSPreterm premature rupture of membranes between 16 0/7 and 33 6/7 weeks gestation |
| Healthy controls | – | Diagnostic Test: mNGSGestational-age-matched controls without preterm premature rupture of membranes or other pregnancy complications |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant patients with preterm premature rupture of membranes and gestational-age-matched controls
Key inclusion criteria (2 listed)
- For PPROM group, preterm premature rupture of membranes between 16 0/7 and 33 6/7 weeks of gestation
- For control group, healthy pregnancy with no evidence of preterm premature rupture of membranes or other major complications
Key exclusion criteria (2 listed)
- Maternal age < 18 years
- Major fetal congenital malformation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mNGSMetagenomic next generation sequencing for microbial DNA | Diagnostic test | Healthy controls, PPROM |
Primary outcome
Length of latency
Time frame: From study enrollment to date of delivery, up to 24 weeks
Time between PPROM and delivery
10 secondary outcomes
Maternal infectious morbidity
Time frame: From study enrollment to date of delivery, up to 30 weeks
Neonatal infectious morbidity
Time frame: From neonatal birth to neonatal hospital discharge, up to 1 year
Histopathological signs of infection
Time frame: At time of placental delivery
Perinatal demise
Time frame: From study enrollment to 28 days of life
Admission to neonatal intensive care unit (NICU)
Time frame: From neonatal birth to neonatal hospital discharge, up to 1 year
NICU length of stay
Time frame: From neonatal birth to neonatal hospital discharge, up to 1 year
Neonatal need for supplemental oxygen
Time frame: From neonatal birth to neonatal hospital discharge, up to 1 year
Respiratory distress syndrome
Time frame: From neonatal birth to neonatal hospital discharge, up to 1 year
Necrotizing enterocolitis
Time frame: From neonatal birth to neonatal hospital discharge, up to 1 year
Intraventricular hemorrhage
Time frame: From neonatal birth to neonatal hospital discharge, up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nasim C Sobhani, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Rupture of Membranes, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of latency (time frame: From study enrollment to date of delivery, up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.